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PREMIER DERMATOLOGY PATRICK KEEHAN, D.O. CYCLOSPORINE Informed Consent GENERAL INFORMATION: Cyclosporine has been used in the field of transplantation to prevent rejection of transplanted human organs for over 20 years. Psoriasis patients being treated with Cyclosporine demonstrate rapid clearing of psoriasis and the drug was officially approved by the FDA for the treatment of psoriasis in 1997. WHAT WILL HAPPEN TO YOU DURING TREATMENT: A full examination will be performed prior to starting treatment with this drug. You will also be asked to complete an extensive medical and family history form. Baseline laboratory evaluations will be obtained, including blood count, blood chemistry, liver function, kidney functions, HIV and hepatitis screen, pregnancy test, if appropriate, and further tests or medical evaluations felt necessary by Dr. Patrick Keehan. Patients that are on this therapy may be required to have a Glofil test, which is a glomerular filtration exam to measure how well your kidneys are functioning. If you area a female and there is the potential for pregnancy (i.e. not surgically sterilized or post-menopausal), we will need your agreement to use a reliable method of birth control (oral contraceptive or double barrier protection). We cannot take responsibility for conception while a woman is on this medication. The dose of Cyclosporine will be carefully prescribed according to your body weight. You will be seen at approximately monthly intervals during the course of your treatment in order to monitor your progress and potential side effects. FACTS YOU SHOULD KNOW: Cyclosporine has the potential to cause side effects, especially on the kidneys. Therefore, we closely monitor blood pressure, blood tests, kidney function tests, and medical findings that relate to kidney function. The dose of Cyclosporine may be periodically adjusted, depending upon your physical exam and lab tests, to minimize the potential for adverse effects. Liver changes may also occur with Cyclosporine, including increased blood levels of the liver enzymes. Thus, only moderate alcohol intake is allowed while you are on Cyclosporine. Levels of uric acid may increase and may provoke flares of gout. Please tell us if you have a history of gout. In addition to potential kidney and liver toxicity, adverse reactions such as tremor, increased hair growth, acne, and excessive growth of the gums may also occur. There is also potential increase in skin tumors and, less frequently, other tumors. Other reactions that occur in 2% or fewer of patients include allergic reactions, anemia, decreased appetite, confusion, eye inflammation, swelling, fever, brittle fingernails, stomach irritation, hearing loss, hiccups, elevated blood sugars, muscle pain, peptic ulcer, decreased platelet counts, and ringing of the ears. Other reactions that occur rarely include: anxiety, chest pain, constipation, hair breakage, blood in the urine, joint pain, lethargy, mouth sores, heart attack, night sweats, pancreatitis, itching, swallowing difficulties, tingling, stomach bleeding, visual disturbances, weakness, and weight loss. You will be very carefully followed by the physician and staff in our practice to monitor any potential side effects, both by examination, as well as by evaluation of laboratory test results. In addition, it will be essential for you to check your blood pressure weekly. PARTICIPATION IN THIS THERAPY: To participate in this treatment, we will need your cooperation. Do not take any prescribed or over-the-counter drug without first notifying the staff at Premier Dermatology, as there are numerous drugs that interact with Cyclosporine. Please inform your physician at each visit that you are being treated with Cyclosporine. You should avoid too much sun exposure and, if you are female, you should have a Pap smear every year
while you are on this medication. Bring any new or changing skin lesions to our attention. Please notify us of any masses or enlarged glands when you are at our office for your regular exams. We will absolutely discontinue your treatment with this drug if you fail to follow instructions, fail to return for your scheduled appointments, or develop significant side effects. In this regard, it is essential that you ensure that all laboratory tests are done in a timely fashion and that the results be sent to our office (if your tests are done in another physician’s office). If we do not receive your results, we will be unable to continue your treatment with Cyclosporine. If you have any questions or problems concerning your treatment with this drug, if you feel you are experiencing side effects, or if you begin taking another drug, please contact Premier Dermatology at 817-769-3603. SUMMARY:
1. Follow the instructions given to you by the physicians and nurses at Premier Dermatology. If you have any
questions, please do not hesitate to call us.
2. Please monitor your blood pressure, as instructed. 3. Do not fail to get blood pressure, as instructed. 4. Do not fail to get blood tests, as instructed. Have the results sent to us promptly. 5. Do not miss appointments. 6. Inform us of any new medications that have been prescribed for you. 7. Moderate alcohol if any. 8. Please contact us immediately at 817-769-3603
I HAVE READ AND UNDERSTAND THE FOREGOING INFORMATION AND INSTRUCTIONS AND I GIVE MY VOLUNTARY CONSENT TO PARTICIPATE. ______________________________________________
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DRUG INTERACTIONS – CYCLOSPORINE (NEORAL)Allopurinol Amiodarone Amphotericin (Fungizone)Azapropazone Bromocriptine (Parlodel)Carbamazepine (Atretol, Tegretol) Cimetidine (Tagamet)Clarithromycin (Biaxin) Colchiane Corticosteroids Danazol (Danocrine, Dalfopristin)Diclofenac (Voltaren) Digoxin (Lanoxin, Lanoxicaps) Diltiazem (Cardizem, Dilacor)Dopamine (Intropin) Erythromycin (Emycin, Eryce, PCE, Ilosone, EES, Eryped, Erytab, Ketek)Fluconazole (Diflucan)Furosemide (Lasix) Gentamicin (Garamycin, G-myticin, Gentamicon)Heparin (Hep-lock) Isoniazid (INH) Itraconazole (Sporanox)Ketaconazole (Nizoral) Ketek (Telithromycin) Lovastatin (Mevacor) Melphalan (Alkeran) Methylpredisolone (Medrol, Depo-Medrol)Metoclopramide (Reglan) Nafcillin Naproxen Norfioxacin (Noroxin)NSAIDSs (Advil, Motrin, Nuprin, Alleve, Ibuprofen, etc.)Octreotide Orlistat Oral contraceptives Phenobarbitol (Donnatal) Phenytoin (Dilantin) Quinupristin Ranitidine (Zantac) Rifampin (Rifadin, Rifamate, Rimactane) St. John’s Wort Sulfamethoxazole/Trimethoprim (Bactrim/Septra) Sulindac Tacrolimus Ticlopidine Tobramycin (Tobradex, Tobrex, Nebcin) Vancomycin (Vancocin, Vancoled) Verapamil (Calan, Isoptin, Verelan) ZofranCYCLOSPORINE PROTOCOL
Patient: ________________________________________
Before starting Cyclosporine/Neoral therapy: